LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX
The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest.

Code Information

Affected Part Numbers: 320371500XXX

Recalling Firm/Manufacturer

Physio-Control, Inc.11811 Willows Rd NeRedmond, Washington 98052-2003

For Additional Information Contact

Physio Control425-867-4000

Manufacturer Reasonfor Recall

Physio-Control has become aware of incidents where customers have attempted to use their
LIFEPAK 1000 defibrillator and the device has shut down unexpectedly due to a very low battery.
A defibrillator in this scenario has the potential to fail to deliver a shock, with the potential result
that therapy is not delivered and a patient is not resuscitated. A software malfunction in the LIFEPAK 100

FDA DeterminedCause 2

PRODUCTION CONTROLS: Software Manufacturing/Software Deployment

Action

On May 9, 2014 Physio-Control sent an Urgent Medical Device Recall Letter (dated May 2014) to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. The customer notification letter will provide new instructions on how to check the functional and power readiness of the device and advise the customer on the actions to take based on the symbol displayed.
Customers are asked to record the readiness indicator(s) shown on each device and fax the confirmation sheet back to Physio-Control at 1-866-448-9567. Customers are also directed to contact Physio-Control at 1-800-442-1142 to obtain replacement batteries, if needed. Customers are provided a Device Readiness Guide for use in interpreting the Readiness Display on the device, and are directed to refer to the Operating Instructions which were provided upon purchase.
In addition to notifying Physio-Control of any potential quality problems or adverse reactions or events experienced associated to the use of these products, Physio-Control asks customers to report directly to the FDA through the MedWatch Adverse Reporting Program online, by regular mail or by fax.
Physio-Control reminds customers that it is critically important in understanding what the device and battery indicators mean on your
defibrillator and what actions you need to take as a result. At any time the battery charge can be verified by following the instruction provided on page 2-5 of the Operating Instructions. It is also important that you always carry a spare fully-charged battery, as stated in the Operating Instructions.
Customers are directed to call Physio-Control at 1-800-442-1142, 6:00 a.m. to 4:00p.m. (Pacific), Monday - Friday for any further questions.